Trial Outcomes & Findings for Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia (NCT NCT00728728)
NCT ID: NCT00728728
Last Updated: 2017-02-10
Results Overview
The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance.
COMPLETED
PHASE2
88 participants
Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
2017-02-10
Participant Flow
Participant milestones
| Measure |
Arm 1: Pregnenolone
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
Placebo control group
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
46
|
|
Overall Study
COMPLETED
|
38
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
Baseline characteristics by cohort
| Measure |
Arm 1: Pregnenolone
n=42 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=46 Participants
Placebo control group
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Gender
Male
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
46 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance.
Outcome measures
| Measure |
Arm 1: Pregnenolone
n=38 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=34 Participants
Placebo control group
|
|---|---|---|
|
MATRICS Consensus Cognitive Battery (MCCB)
Baseline
|
30.92 T score
Standard Error 1.83
|
30.32 T score
Standard Error 1.40
|
|
MATRICS Consensus Cognitive Battery (MCCB)
Week 4
|
33.43 T score
Standard Error 1.75
|
32.76 T score
Standard Error 1.72
|
|
MATRICS Consensus Cognitive Battery (MCCB)
Week 8
|
36.97 T score
Standard Error 1.90
|
34.25 T score
Standard Error 2.11
|
PRIMARY outcome
Timeframe: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.
Outcome measures
| Measure |
Arm 1: Pregnenolone
n=38 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=34 Participants
Placebo control group
|
|---|---|---|
|
University of California Performance-based Skills Assessment (UPSA)
Baseline
|
77.49 total score
Standard Error 1.63
|
76.68 total score
Standard Error 1.76
|
|
University of California Performance-based Skills Assessment (UPSA)
Week 4
|
77.29 total score
Standard Error 2.65
|
80.12 total score
Standard Error 1.63
|
|
University of California Performance-based Skills Assessment (UPSA)
Week 8
|
85.63 total score
Standard Error 1.31
|
82.03 total score
Standard Error 2.05
|
PRIMARY outcome
Timeframe: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory \& Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.
Outcome measures
| Measure |
Arm 1: Pregnenolone
n=38 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=34 Participants
Placebo control group
|
|---|---|---|
|
Brief Assessment of Cognition in Schizophrenia (BACS)
Baseline
|
-1.37 Z score
Standard Error 0.13
|
-1.53 Z score
Standard Error 0.12
|
|
Brief Assessment of Cognition in Schizophrenia (BACS)
Week 4
|
-1.11 Z score
Standard Error 0.14
|
-1.17 Z score
Standard Error 0.12
|
|
Brief Assessment of Cognition in Schizophrenia (BACS)
Week 8
|
-0.79 Z score
Standard Error 0.13
|
-1.09 Z score
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.
Outcome measures
| Measure |
Arm 1: Pregnenolone
n=38 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=34 Participants
Placebo control group
|
|---|---|---|
|
Scale for the Assessment of Negative Symptoms(SANS)
Baseline
|
26.92 total score
Standard Error 1.75
|
25.88 total score
Standard Error 1.94
|
|
Scale for the Assessment of Negative Symptoms(SANS)
Week 4
|
23.87 total score
Standard Error 2.05
|
21.74 total score
Standard Error 1.87
|
|
Scale for the Assessment of Negative Symptoms(SANS)
Week 8
|
21.00 total score
Standard Error 2.47
|
20.77 total score
Standard Error 2.40
|
SECONDARY outcome
Timeframe: Prospective, outcome measures collected over 10 week trial period.The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.
Outcome measures
| Measure |
Arm 1: Pregnenolone
n=38 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=34 Participants
Placebo control group
|
|---|---|---|
|
The Calgary Depression Scale for Schizophrenia (CDSS)
Baseline
|
2.84 total score
Standard Error 0.64
|
3.18 total score
Standard Error 0.64
|
|
The Calgary Depression Scale for Schizophrenia (CDSS)
Week 4
|
2.39 total score
Standard Error 0.62
|
2.79 total score
Standard Error 0.66
|
|
The Calgary Depression Scale for Schizophrenia (CDSS)
Week 8
|
2.68 total score
Standard Error 0.74
|
2.46 total score
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.
Outcome measures
| Measure |
Arm 1: Pregnenolone
n=38 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=34 Participants
Placebo control group
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
65.74 total score
Standard Error 2.28
|
63.68 total score
Standard Error 2.58
|
|
Positive and Negative Syndrome Scale (PANSS)
Week 4
|
61.47 total score
Standard Error 2.55
|
56.79 total score
Standard Error 2.03
|
|
Positive and Negative Syndrome Scale (PANSS)
Week 8
|
59.10 total score
Standard Error 2.95
|
57.12 total score
Standard Error 3.16
|
SECONDARY outcome
Timeframe: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)Population: Missing data for a total of 5 participants for the CGI.
The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.
Outcome measures
| Measure |
Arm 1: Pregnenolone
n=34 Participants
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=33 Participants
Placebo control group
|
|---|---|---|
|
Clinical Global Impressions (CGI) Scale
Baseline
|
3.56 score
Standard Error 0.15
|
3.58 score
Standard Error 0.13
|
|
Clinical Global Impressions (CGI) Scale
Week 4
|
3.39 score
Standard Error 0.12
|
3.39 score
Standard Error 0.14
|
|
Clinical Global Impressions (CGI) Scale
Week 8
|
3.42 score
Standard Error 0.12
|
3.24 score
Standard Error 0.17
|
Adverse Events
Arm 1: Pregnenolone
Arm 2: Placebo
Serious adverse events
| Measure |
Arm 1: Pregnenolone
n=42 participants at risk
Pregnenolone
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=46 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Hopitalization
|
4.8%
2/42
|
4.3%
2/46
|
|
Endocrine disorders
Hospitalization for Elevated Glucose
|
2.4%
1/42
|
0.00%
0/46
|
|
Gastrointestinal disorders
Medical Admission for Observation
|
0.00%
0/42
|
2.2%
1/46
|
|
Reproductive system and breast disorders
Breast Cancer Diagnosis
|
0.00%
0/42
|
2.2%
1/46
|
Other adverse events
| Measure |
Arm 1: Pregnenolone
n=42 participants at risk
Pregnenolone
Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
|
Arm 2: Placebo
n=46 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
26.2%
11/42
|
21.7%
10/46
|
|
Nervous system disorders
Hypersomnia
|
21.4%
9/42
|
17.4%
8/46
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
8/42
|
15.2%
7/46
|
|
Nervous system disorders
Insomnia
|
16.7%
7/42
|
6.5%
3/46
|
|
Nervous system disorders
Decreased Appetite
|
19.0%
8/42
|
13.0%
6/46
|
|
Nervous system disorders
Increased appetite
|
16.7%
7/42
|
19.6%
9/46
|
|
Gastrointestinal disorders
Constipation
|
11.9%
5/42
|
26.1%
12/46
|
|
Gastrointestinal disorders
Nausea
|
14.3%
6/42
|
4.3%
2/46
|
|
Nervous system disorders
Dry mouth
|
11.9%
5/42
|
17.4%
8/46
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
16.7%
7/42
|
13.0%
6/46
|
|
Nervous system disorders
Headache
|
14.3%
6/42
|
19.6%
9/46
|
|
Nervous system disorders
Tremor
|
11.9%
5/42
|
10.9%
5/46
|
|
Nervous system disorders
Increased Salivation
|
11.9%
5/42
|
2.2%
1/46
|
|
Cardiac disorders
Palpitations
|
9.5%
4/42
|
15.2%
7/46
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
3/42
|
10.9%
5/46
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
7.1%
3/42
|
8.7%
4/46
|
|
Musculoskeletal and connective tissue disorders
Joint pain/ stiffness
|
11.9%
5/42
|
4.3%
2/46
|
|
Nervous system disorders
Dizziness
|
9.5%
4/42
|
19.6%
9/46
|
|
Nervous system disorders
Sweating
|
4.8%
2/42
|
2.2%
1/46
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42
|
4.3%
2/46
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain/Stiffness
|
7.1%
3/42
|
8.7%
4/46
|
|
Nervous system disorders
Other: "Lucid Dreams"
|
2.4%
1/42
|
0.00%
0/46
|
|
General disorders
Restlessness
|
7.1%
3/42
|
8.7%
4/46
|
|
Renal and urinary disorders
Nocturnal/Enuresis
|
2.4%
1/42
|
2.2%
1/46
|
|
Nervous system disorders
Decreased Interest in Sex
|
4.8%
2/42
|
0.00%
0/46
|
|
Nervous system disorders
Vertigo
|
2.4%
1/42
|
0.00%
0/46
|
|
Eye disorders
Blurred Vision
|
2.4%
1/42
|
8.7%
4/46
|
|
Reproductive system and breast disorders
Menstrual Disturbance
|
2.4%
1/42
|
0.00%
0/46
|
|
General disorders
Nasal Congestion
|
2.4%
1/42
|
8.7%
4/46
|
|
General disorders
Peripheral Edema
|
2.4%
1/42
|
2.2%
1/46
|
|
General disorders
Malaise
|
2.4%
1/42
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Akathisia
|
2.4%
1/42
|
0.00%
0/46
|
|
Nervous system disorders
Excitement/Agitation
|
2.4%
1/42
|
2.2%
1/46
|
|
Nervous system disorders
Confusion
|
2.4%
1/42
|
4.3%
2/46
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/42
|
4.3%
2/46
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/42
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Increased Motor Activity
|
0.00%
0/42
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
Cold Extremities
|
0.00%
0/42
|
2.2%
1/46
|
|
Renal and urinary disorders
Other: "Urinary Retention"
|
0.00%
0/42
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
Other: "Head/Neck Twitching"
|
0.00%
0/42
|
2.2%
1/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place